MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM; ORTHOPEDIC NAIL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the part number and lot number of the device was not reported to paragon 28.Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.Reasonable efforts were made to obtain case information however, the reporter was not responsive.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a surgical procedure that utilized paragon 28 phantom small bone intramedullary nail system.The lapidus nail was reported broken post-operatively.The surgeon's post-operative protocol was reported as 2 weeks non-weight bare, 2 weeks touch weight , 2 weeks partial weight and then 6 weeks full weight bare.Two broken nails was reported.This report addresses the second nail reported broken.

• Brand Name: PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
• Type of Device: ORTHOPEDIC NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10988303
• MDR Text Key: 221518377
• Report Number: 3008650117-2020-00253
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1